510(k) Report

FDA applicant

Fcu Co., Ltd.

Yuseong-Gu, KR2 decisions2021–20240 recalls

FDA records 2 decisions for Fcu Co., Ltd. (Yuseong-Gu, KR) from 2021 to 2024: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Fcu Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Fcu Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd. · 2024
  • K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd. · 2021

All 2 as Fcu Co., Ltd. →